Landmark overhaul of drug research is proposed in the House

Leaders of the House Energy and Commerce Committee on Wednesday unveiled a long-awaited draft of legislation that would speed up the approval of new drugs and treatments.

The bipartisan, multi-billion dollar initiative, known as 21st Century Cures, includes major overhauls of the Food and Drug Administration (FDA) as well as the National Institutes of Health (NIH).

{mosads}Specifically, the bill would reform the government’s rules for clinical trials, create new incentives for drug companies to study rare diseases and put a far greater focus on patient data to move toward “personalized medicine,” according to the 200-page draft.

It would also add $10 billion to the NIH’s budget over five years. Funding for had agency had been a major sticking point in the talks.

The latest version of the bill is the result of more than a year of negotiations between Commerce Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Col.), as well as dozens of companies and government officials. It is about half the size of the previous version in January, which was more than 400 pages but was not endorsed by any Democrats.

Health research and patient groups on Wednesday touted the potential funding increase for the NIH, which comes after two years of battling over sequestration cuts.

The question of what to do about NIH funding had been divisive, and was one of several issues holding up the release of the text.

The proposed funding level would exceed President Obama’s budget request this year by more than $1 billion. The committee is still deciding how the funding increases will be offset, if at all, according to an aide. Any new discretionary dollars would need to be offset under existing budget rules.

The annual NIH budget would increase to $31.8 billion next fiscal year and reach $34.8 billion within two years. The legislation would also create a $2 billion per year “innovation fund” for the NIH through 2020.

The three-year budget plan for the NIH would mark a major shift from previous years, when lawmakers approved the agency’s funding one year at a time. Stabilizing the level of funding is an important step, said former FDA commissioner Andy von Eschenbach.

“That may seem trivial, but that’s really a very profound improvement in the way in which we can manage our investments in biomedical research,” von Eschenbach said Wednesday.

As a former NIH official under the Clinton administration, von Eschenbach said he remembers when Congress doubled the NIH budget but failed to make any other reforms to the agency.

“We realized, ‘Well we actually haven’t completed solved the problem,’” he said. “What this bill is saying, ‘Let’s be strategic about more resources but lets also be strategic about how we’re spending them.’ ”

The committee’s text leaves out two of the more complicated areas: telemedicine and interoperability. The draft legislative language in both areas will be released “shortly,” the committee’s document reads.

Members reached a deal late Tuesday afternoon, a committee aide said Wednesday. The latest version of legislative text was slated to be released as early as last Wednesday, but the negotiations had been held up, in part, by disputes over NIH funding and incentives for drug companies.

“I will say, there are naysayers on both sides. Democrats come to me and they say, don’t let them take advantage of you,” DeGette said earlier this week in a joint interview with Upton. “We still have some issues we need to resolve, but we’re optimistic that we’ll be able to do that.”

The full committee will meet Thursday to discuss the draft with officials from both the FDA and the NIH.

The House committee has been developing its medical innovations bill at the same time as another Senate committee — but separately.

Shortly after the House draft was released on Wednesday, the Senate’s health committee said it is forming a bipartisan working group to improve electronic health records – one of the areas left out of the House bill.

Marc Boutin, CEO of the National Health Council, said he hopes the Senate and House can eventually “reach common ground” to send legislation to the president.

“I think the Senate approach will be to start smaller and expand. The House approach has been, ‘Let’s be very, very broad, and then narrow,’ ” he said.

— This story was last updated at 5:04 p.m.